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Another year down (and only one more to go for Bexis), and that means, in addition to dreidels, creches, and Santa Claus, it’s time for our annual top ten best prescription medical product liability litigation decisions.  As we’ve pointed out before, for an opinion to be eligible for our annual top (or bottom) ten lists, it must:  (1) involve a prescription medical product, or an OTC drug, and (2) have a plaintiff asserting liability for something purportedly wrong with that product.

So, before we turn to the best of the best for 2024, we’re going to give passing reference to those non-prescription medical product or non-product liability decisions in 2024 that we think will significantly impact our sandbox in years to come.

First on the list is no surprise, Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024), holding that courts owe no deference to administrative agency interpretations of their own statutory schemes.  For us, of course, that primarily means the FDA.  We’ve already discussed two opportunities and one defensive strategy that we see arising from Loper Bright.  Loper Bright will work in tandem with Corner Post, Inc. v. Board of Governors of Federal Reserve System, 144 S. Ct. 2440 (2024), discussed here, a decision making it much easier to avoid the six-year statute of limitations that the Administrative Procedure Act imposes for challenging the kind of government actions at issue in Loper Bright.

Other non-prescription medical product decisions of significance in 2024 are:  FDA v. Alliance for Hippocratic Medicine, 602 U.S. 367 (2024), rejecting, on standing grounds, a frontal assault on the FDA’s authority to approve prescription drugs (here, and here); S.K. v. Obstetrics & Gynecologic Associates of Iowa City & Coralville, P.C., ___ N.W.2d ___, 2024 WL 4714425 (Iowa Nov. 8, 2024), holding that FDA labeling is not proof of medical malpractice in an off-label use case (here); Francisco v. Affiliated Urologists Ltd., 553 P.3d 867 (Ariz. 2024), similarly rejecting FDA regulated labeling as proof of the medical standard of care in an informed consent case involving a boxed warning (here); Politella v. Windham Southeast School Dist., 325 A.3d 88 (Vt. 2024), while Vermont has one of the most liberal high courts, it recognized the full preemptive scope of the PREP Act in a vaccination-related suit (here); Schaffner v. Monsanto Corp., 113 F.4th 364 (3d Cir. 2024), an excellent RoundUp preemption decision, also significant for creating a potentially certworthy circuit split (here); In re Deepwater Horizon Belo Cases, 119 F.4th 937 (11th Cir. 2024), an outstanding Rule 702 general causation case rejecting yet another version of a no minimum exposure level claim (here); Children’s Health Defense v. FDA, 2024 WL 244938 (5th Cir. Jan. 23, 2024), rejecting, on standing grounds, a parent’s challenge to FDA public service pro-vaccine messaging (here); In re Paraquat Products Liability Litigation, 730 F. Supp.3d 793 (S.D. Ill. 2024), a thorough MDL-wide expert exclusion decision faithfully applying the amended Rule 702 standards and holding that subjective “weight of the evidence” opinions were inadmissible (here).

But that doesn’t in any way mean that our top ten decisions aren’t also significant, particularly since they are directly applicable, and not merely analogous, to the arguments we make in defense of our prescription medical product clients.  This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert.  Some excluded bogus expert testimony under Fed. R. Civ. P. 702 (don’t say Daubert), both before and after the new, more muscular version of Rule 702 debuted on December first of 2023.  Others applied the learned intermediary rule, another of our favorite defenses.  They blew out nuclear verdicts.  They rejected novel liability theories and even trimmed large numbers of cases from our increasingly dysfunctional and lawless federal multi-district litigation system (which has grown to nearly 80% of the total federal docket).  Some even do more than one of these things.  So here they are, our 2024 top ten prescription medical product liability decisions.

  1. Shears v. Ethicon, Inc., 902 S.E.2d 775 (W. Va. 2024).  It’s a little late, since all those pelvic mesh MDLs have run their course, but yes, West Virginia does require a plaintiff to prove an alternative design as an essential element of a strict liability design defect claim.  One could also say it’s a little late for this particular case, but that is the nature of MDLs.  The Shears case was also a pelvic mesh matter, and it had been pending in one of those MDLs for some seven years, so it was more than a decade old before the necessary elements of the design claim were established.  The plaintiff had argued for no alternative at all, while the defendant’s position in Shears was (based in a standard jury instruction) that the alternative design had to eliminate, not merely reduce, the causal risk.  Shears did not go quite that far, but confirmed that no West Virginia plaintiff can get to a jury on a design defect claim without proof of the existence of an alternative, feasible design that existed when the product was manufactured.  Because product designs in West Virginia must be “reasonably safe” – which is essentially a negligence, rather than a strict liability, standard – the alternative design must not merely be “safer” (the plaintiff’s fall-back position), but must “substantially reduce” the relevant risk.  Plaintiff’s “safer” standard, which is also the formulation used in the Third Restatement of Torts §2, was too vague, and thus an “ineffective” basis for jury assessment of the duty of a “reasonably prudent manufacturer.”  True enough, the defendant didn’t get the even tougher standard from the jury instruction, but overall we’re more than satisfied, and even a bit jealous, particularly those of us who practice in Pennsylvania.  As a state high court decision on a fundamental product liability issue that adopted a liability standard more stringent than the Restatement, Shears qualifies as our best decision of the year.  We saluted Shears here.
  2. Hickey v. Hospira, Inc., 102 F.4th 748 (5th Cir. 2024).  The Taxotere MDL has, frankly, been a disaster for plaintiffs.  That’s become quite clear for at least the last couple of years or so.  While it can’t compete yet with Bone Screw (no equivalent of Buckman), Hickey gets it closer.  In Hickey the Fifth Circuit became the first appellate court to recognize extensive federal preemption for medical devices coming to market under 21 U.S.C. §355(b)(2) – the FDA’s successor to so-called “paper NDAs.”  Appellate recognition of preemption for a new class of prescription medical products doesn’t happen every day, so Hickey is our number two decision of the year.  This type of FDA product approval is intermediate between traditional new drug applications and the abbreviated ANDA for generic drugs.  This preemption-friendly result required a number of favorable intermediate steps of its own.  First, lack of “newly acquired information” is a separate basis for preemption, apart from the Albrecht (2019+1) “clear evidence standard.  Without such evidence, the requirements of the FDA’s preemption determinative “changes being effected” (“CBE”) regulation cannot be satisfied.  Second, the CBE regulation requires that such evidence not only be “new” but also “reveal risks of a different type or greater severity or frequency” than material already in the FDA’s possession.  Third, plaintiffs offered only “cumulative” information with no significant change in the degree of risk.  Fourth, adverse events of the sort plaintiffs alleged proved nothing by themselves because the denominator (number of patients treated) was so large.  One minor question – about the interpretation of a particular medical abstract – was remanded, with the appellate court’s express direction that otherwise the defendants were “not liable” on failure to warn claims due to implied preemption.  We hailed Hickey here.
  3. This entry is solely from the Holland & Knight side of the Blog.  In re National Prescription Opiate Litigation, ___ N.E.3d ___, 2024 WL 5049302 (Ohio Dec. 10, 2024) (“Trumbull County”).  The expansion of public nuisance as a vehicle for shifting governmental costs to private entities has been, well, a nuisance for a while.  When it comes to this particular litigation, currently the primary driver of that expansion, however, we have been biting our proverbial collective tongues more than usual.  The recent Trumbull County decision, on a certified question from the Sixth Circuit gave one of us a chance to address some of these issues.  In our Top Ten posts in each of the last two years, we noted we were watching the appeal following a large plaintiff verdict and then the referral to the Ohio Supreme Court for an answer to the basic question of whether Ohio still has a common-law public nuisance claim based on products claimed to interfere with a public interest.  Trumbull County answered that question in the negative.  The “unorthodox” product-related public nuisance theory, that Ohio once recognized in a non-prescription medical product liability case, was since completely abrogated by two statutory amendments to the Ohio product liability statute.  Thus, a nine-figure MDL verdict should vanish, and future Ohio defendants can breathe easier.  Trumbull County’s usefulness is somewhat limited because it concerned the statutory law of one state, but nonetheless it is definitely important given the history of these claims and the breadth of MDL litigation.  In terms of that history, the Blog addressed many years ago restrictions from the municipal recovery doctrine (here and later here), issues with governmental outsourcing to contingency fee plaintiff lawyers, and that a trial run with the meth epidemic failed during the Breaking Bad era.  All of this foreshadowed years of litigation with the specter of virtually unlimited liability when it came to the enormous costs of the opioid epidemic.  Some of us trumpeted Trumbull here.
  4. In re Onglyza & Kombiglyze Products Liability Litigation, 93 F.4th 339 (6th Cir. 2024).  Plaintiff-side counsel have been desperate to find some way to create a mass tort out of the very popular – and very safe – saxagliptin-based diabetes drugs.  Their first major try was an MDL claiming that the drugs caused heart failure.  But there is no valid scientific basis for that allegation, as a California appellate court concluded last year (2023+5).  In O&K the Sixth Circuit affirmed the federal MDL judge’s order excluding the plaintiffs’ general causation expert and granting summary judgment.  O&K held that, under either the prior or amended version of Fed. R. Evid. 702, none of the plaintiffs’ experts’ causation opinions were based on sufficient facts or reliable methodology, and therefore defendants were entitled to summary judgment – making this our best expert-related decision of the year.  The plaintiffs’ case rested on one result of a multiple-endpoint trial conducted at the request of the FDA.  The authors of the study regarded that result as a likely false positive.  There were a number of other studies that found no association.  Plaintiffs’ expert ignored all of those, claiming they suffered from never-identified “confounding” factors.  The one other study that the excluded expert relied on did not focus on the claimed injury and found “no known mechanism” for these drugs causing that type of injury.  O&K affirmed the unreliability of the expert’s broad exclusion of all other studies from his consideration.  Also affirmed was the conclusion that the expert was incompetent even to analyze certain animal data that he claimed also supported his opinion.  As do most p-side experts, this expert also abused poor Dr. Bradford-Hill’s causation criteria.  He cherry picked data using blatantly result-oriented selection criteria.  At this point, O&K expressly cited to the 2023 Rule 702 amendments requiring affirmative proof of a “reliably applied” methodology – the first post-Amendments Court of Appeals decision to do so.  After affirming the expert exclusion, O&K rejected plaintiffs’ last-ditch claim that their own hard-fought experts didn’t even matter, because expert causation opinions were not necessary.  O&K found that no-expert argument to be contrary to the laws of all 50 states.  Nor, having advanced a bogus expert, were plaintiffs entitled to a do-over.  The trial court acted within its discretion in not allowing the MDL plaintiffs to “restart expert discovery.”  Plaintiffs should not be “reward[ed]” for “their failure to identify a reliable general causation expert” the first time around.  We wrote that we were more than just okay with O&K here.
  5. Bueno v. Merck & Co., ___ F. Supp.3d ___, 2024 WL 3974754 (S.D. Cal. Aug. 27, 2024), and Parker v. Merck & Co., 2024 WL 3974764 (S.D. Cal. Aug. 27, 2024).  These two opinions involved the same product, and mostly the same issues, and were decided on the same day.  They rate as our best trial-level decisions of 2024.  Interestingly, an earlier jurisdictional decision in the same litigation was bad enough to make our bottom ten list (2022-9).  We consider Bueno the lead decision because it addressed more issues, specifically choice of law, which is important because the plaintiffs in this litigation all took a generic drug, and filed suit in California to take advantage of that state’s awful (and essentially unique) innovator liability theory (2017-1).  After Bueno, these plaintiffs’ forum shopping looks like a bad job.  All of the relevant conduct took place in the state where the plaintiff lived at the time he used the defendant’s drug, so the mere continuation of his claimed injury after moving to California did not overcome all the other facts relevant to choice-of-law analysis.  The law of the state where the plaintiff’s medical treatment and concomitant product use occurred applied, so the Bueno plaintiff could not assert California innovator liability.  That killed the claims in Bueno, and since very few other plaintiffs likely even had moved to California after the fact, other forum-shopping plaintiffs in this litigation should likewise get the boot.  Parker involved a California citizen, so choice of law was not an issue.  But the favorable rulings continued.  First, neither plaintiff had any expert opinion for why the drug’s warning labels were inadequate.  Second, both plaintiffs’ prescribers gave excellent warning causation testimony, mostly that none of the plaintiffs’ warning-related nit-picks would have affected either the prescriptions or the informed consent discussions.  Third, both plaintiffs’ warning causation testimony was horrible (for them, not for the defendant) – specifically that they wanted to continue using the defendant’s product even after the boxed warning, and thus concealed aspects of their medical history from their own doctors so they could.  Clearly, their counsel did not vet these plaintiffs ahead of time.  Fourth, the plaintiffs’ claims (all involving warnings) were preempted.  The FDA had already received lots of adverse reports by the time these plaintiffs used the products, so there was nothing “new.”  Nor could plaintiffs defeat preemption by alleging that the defendants should have done more studies that might have created “new” information.  The plaintiffs’ experts’ opinions opposing preemption were just as bad, if not worse, than their opinions on warning adequacy.  Thus, Bueno/Parker produced favorable decisions on:  (1) choice of law, (2) warning adequacy; (3) the learned intermediary rule/warning causation under the new Himes (2024-3) causation standard; (4) plaintiff-related warning causation; and (5) prescription drug preemption.  We ballyhooed Bueno and praised Parker here.
  6. Dickson v. Dexcom, Inc., 2024 WL 3417392 (W.D. La. July 15, 2024).  As already mentioned in connection with the Hickey case, preemption isn’t extended to a new type of prescription medical product every day.  In 2024 that happened twice.  Dickson broke important new ground in holding that a particular type of Class II medical device – receiving this FDA classification under the agency’s “de novo” approval process – is protected by preemption from product liability litigation challenging the device’s safety and effectiveness.  Pursuant to this “de novo” process, added to the FDCA as 21 U.S.C. §360c(f)(2)(A)(iii) in 1997, the device was “subject to certain mitigation measures for its identified risks” as FDA “special controls” uniquely applicable to the design that particular device.  That pushed the device in Dickson to the good side of the “device-specific requirement” gloss on the statute’s express preemption language imposed by the Supreme Court in Medtronic v. Lohr.  That was the hard part.  Ever since Lohr imposed extra-statutory limits on preemption back in 1996 (through analysis now prohibited by Loper Bright), courts have slavishly followed Lohr and deprived Class II devices of just about all preemption defenses.  Preemption having surmounted that hurdle in Dickson, the decision had little trouble with the plaintiff’s claims being “different from, or in addition to” the requirements that the FDA had imposed via its de novo review.  The plaintiff did not allege any noncompliance with those federal requirements, attacking instead “both the safety of the product’s design and the adequacy of its label notwithstanding the FDA’s approval.”  Initially, the plaintiff mistakenly received leave to amend to assert a preemption exception under the FDA’s CBE regulations, which do not even apply to de novo review devices, but that mistake has since been corrected, see Dickson v. Dexcom Inc., 2024 WL 4291511 (W.D. La. Sept. 25, 2024).  Plaintiff did not appeal, and the time for doing so has passed.  We delighted in Dickson here.
  7. In re Zostavax Products Liability Litigation, 2024 WL 3423709 (3d Cir. July 16, 2024).  Given how much we love Lone Pine orders in MDL litigation, Zostavax would have been much higher than this had it only been published.  We think every MDL should have one entered during the first year of litigation.  Unfortunately, that almost never happens, and didn’t happen here.  Nonetheless, better late than never, and even this late Lone Pine order resulted in the dismissal of over 1,000 plaintiffs (1,189, to be exact) who failed to comply.  The original Zostavax Lone Pine order made our 2022 top ten for that reason (2022+10).  Now, it’s been affirmed.  These plaintiffs claimed that the defendant’s attenuated-virus shingles vaccine actually caused them to suffer singles.  But the same virus that causes shingles in adults causes chickenpox in children, and the virus will persist.  To rule out the ubiquitous natural virus, and rule in the defendant’s vaccine, required a particular genetic test, since the two viruses’ genetic makeup differed.  Hence, the Lone Pine order, which required genetic testing.  The plaintiffs failed to comply – indeed compliance was impossible because the test had to be administered while the shingles infection was active, which was before they filed suit (yet another instance of MDL indiscriminate plaintiff solicitation).  Plaintiffs first claimed that there might be some alternative to the genetic test for them to prove causation, but since they hadn’t found any in over three years of litigation, such speculation was contrary to the “uncontradicted” record.  Further, it was not an abuse of discretion to enter a Lone Pine order that was impossible to fulfill.  That just confirmed that plaintiffs had no causation evidence, or even a theory.  Nor did any procedural requirement preclude dismissal with prejudice prior to summary judgment.  Three years of litigation provided all the process that was due.  Finally, noncompliance with the Lone Pine order met all of the relevant standards for with-prejudice dismissal.  Plaintiffs had non-meritorious cases, since for years they failed to offer anything to show that they could ever prove causation as required by state law.  We zeroed in and then zeroed out Zostavax here.
  8. Oglesby v. Medtronic, Inc., 2024 WL 1283341 (5th Cir. March 26, 2024).  Unfortunately unpublished, Oglesby affirms an excellent result under the product liability law of a very large state, Texas.  Supposedly, a spinal implant disintegrated inside the plaintiff’s body.  Plaintiff attempted to plead a manufacturing defect, but as all-too-often happens with that type of claim, plaintiffs completely failed to allege what the purported defect might be.  Manufacturing defects must involve a deviation from the product’s intended condition.  That doesn’t happen all that often, and the plaintiff did not allege that it happened in Oglesby.  Instead, the plaintiff alleged a “malfunction.”  However, that dog doesn’t hunt in Texas, and the decision thoroughly discusses the state law supporting that result.  “[P]laintiffs must allege a specific deviation from the product’s intended design that allegedly caused the injury.”  That a defect may ultimately be proven circumstantially, does not relieve plaintiffs of the requirement to state the existence of a specific defect “in the first place.”  That’s one.  In addition, Oglesby is a nice appellate addition to our collection of physician failure-to-read causation wins.  Good prescriber testimony sealed the plaintiff’s fate.  The prescriber had no recollection of ever reading either the product manual or its instructions for use.  Plaintiff offered no contradictory evidence, so summary judgment against the warning claim was also affirmed.  Would have ranked considerably higher if published.  We ogled Oglesby here.
  9. Himes v. Somatics, LLC, 549 P.3d 916 (Cal. 2024).  Himes showed up, deservedly, on this year’s worst ten cases (2024-3) for unduly complicating learned intermediary causation and encouraging plaintiffs to claim that it is okay for them to disregard medical advice.  Nonetheless, it also definitively rejected several extreme p-side arguments that we’ve all-too-frequently seen advanced in learned intermediary cases, so Himes also warrants an (albeit lower) entry on this years’ best of list.  Here’s how Himes ensured that the learned intermediary rule remains alive and well (if, unfortunately, harder to win with as a matter of law) in California.  First, it flatly rejected plaintiffs’ kooky argument that the rule should be abolished outright, so that the duty to warn ran solely to lay patients.  Second, Himes reaffirmed that court’s earlier ruling in Brown that prescription medical products are different from ordinary consumer products, so the “expectations” that a consumer has of prescription products are correctly measured by what they learn from their prescribing physicians.  Third, Himes is the first California Supreme Court decision applying the learned intermediary rule to medical devices.  Fourth, Himes rejected plaintiffs’ argument that the rule was some sort of defense on which defendants should bear the burden of proof.  No, “the learned intermediary doctrine is neither a defense nor an exception to a traditional duty rule.”  Fifth, also out the window went plaintiffs’ argument that the rule ceases to apply where a plaintiff alleges that a manufacturer failed to provide an adequate warning.  That would also have abolished the rule, since plaintiffs always claim warnings are inadequate; that being an essential element of a warning-based claim.  Sixth, and finally, Himes’ objective prudent patient standard for causation at least means that plaintiffs cannot prove causation with their own subjective and “self-serving” testimony that they would have declined their doctors’ recommended treatment had they only known whatever additional information is at issue in any given case.  We harmonized the half of Himes we liked here.
  10. In re Oral Phenylephrine Marketing & Sales Practice Litigation, ___ F. Supp.3d ___,  2024 WL 4606818 (E.D.N.Y. Oct. 29, 2024).  Oral Phenylephrine is an important OTC preemption win that disposes of most of the claims in this MDL.  As with most OTC drug litigation these days, the MDL consists of no-injury class actions brought by plaintiffs who were not injured by the product in any way other than, after consuming it, wanting their money back.  Because no personal injuries are at issue, the product liability exception to an otherwise strong FDCA preemption clause concerning these products is inapplicable.  Essentially the Oral Phenylephrine plaintiffs assert that, contrary to the in-force FDA approval, the active ingredient for which the MDL is named is ineffective.  The preemption clause not only contains the familiar “different from”/“in addition to” language, but also a further “not identical to” restriction on state-law allegations.  The familiar preemption syllogism that FDA says “yes,” so plaintiffs cannot say “no” applies.  Plaintiffs could not sue the defendants for labeling that complied with the FDA monograph, and nothing in that monograph created a freestanding duty to update product indications in response to claimed new scientific information.  Questions limited to efficacy did not make these drugs “dangerous to health.”  Nor did it matter how plaintiffs styled their attacks on the drugs’ labeling.  “False advertising,” “false concealment,” “express warranty” and consumer protection (NY) claims all attacked labeling consistent with the monograph language on the approved indication.  Since those claims would have forced defendants to change the drug’s labels or else stop selling the products altogether, every claim was preempted.  One claim wasn’t preempted because it was federal – RICO.  The plaintiffs, however, were all indirect purchasers, and thus lacked standing to sue.  We offered praise for Oral Phenylephrine here.

So those are our top ten of 2024.  These represent our attempt to rank which prescription medical product liability decisions from this year are likely to have the most favorable impact on drug/medical device – and, yes, vaccine − decisions going forward.  If you were involved in any of these cases (except maybe Himes), we at the Blog congratulate you.  Otherwise, we will wait together for next year.

However, we’re not done.  We enjoy extolling defense wins (as if you couldn’t tell), so here is our annual list of runners up − those decisions that we consider to be the next ten most significant wins of 2024.

Honorable Mentions:  (11) Sprafka v. Medical Device Business Services, Inc., 2024 WL 1269226 (D. Minn. March 26, 2024) (rejecting plaintiff’s causation and design expert testimony and granting summary judgment; causation claims both cherry-picked data and improperly relied on MAUDE adverse event reports; design opinion based on untested alternatives and “weight of the evidence”; might have ranked higher if amended Rule 702 properly applied) (here); (12) In re Avandia Marketing, Sales Practices & Products Liability Litigation, 2024 WL 4582876 (E.D. Pa. Oct. 25, 2024) (two p-side frequent flyer economist experts excluded at the class certification stage for using rigged, result oriented methodology and making unsupported and illogical assumptions, leaving plaintiffs without any testimony in support of economic loss class actions, which we hope heralds the final demise of this long-running and utterly meritless MDL; would have ranked higher had it applied proper Rule 702 standards) (here); (13) Caston v. F. Hoffman-La Roche, Inc., 729 F. Supp.3d 930 (N.D. Cal. 2024) (unprecedented successful application of the political questions doctrine as a defense in prescription medical product liability litigation; also a favorable generic preemption ruling) (here); (14) In re Gardasil Products Liability Litigation, ___ F. Supp.3d ___, 2024 WL 3647910 (W.D. N.C. July 31, 2024) (plaintiffs who filed unsuccessful Vaccine Act claims cannot use subsequent product liability litigation to collaterally attack the findings of the Vaccine Court) (here) (15) In re Acetaminophen-ASD-ADHD Products Liability Litigation, 2024 WL 3357608 (S.D.N.Y. July 10, 2024) (we didn’t blog about this favorable expert exclusion decision because it was too similar to a prior excellent decision (2023+4) in the same litigation, but it’s worthy of mention here because it threw out a do-over p-side expert and enabled summary judgment against the entire MDL); (16) In re Chantix (Varenicline) Marketing, Sales Practices & Products Liability Litigation, 2024 WL 2784234 (S.D.N.Y. May 28, 2024) (rejecting many of the same unprecedented liability theories allowed in the Valsartan MDL (2023-1, 2021-4), mostly as Buckman-preempted private FDCA enforcement; only manufacturing defect claims left) (here); (17) Brashear v. Pacira Pharmaceuticals, Inc., 2024 WL 3860465 (S.D. Ohio Aug. 19, 2024) (excellent prescription drug preemption decision on both warning (newly acquired information) and design (stop-selling) claims) (here); (18) O’Haver v. 3M Co., 698 S.W.3d 730 (Mo. App. 2024) (published affirmance of Bair Hugger defense verdict; defendant’s internal litigation-driven product review properly held privileged; no abuse of discretion restricting plaintiff’s cross-examination of defense experts since plaintiff had equal time; other issues waived) (here); (19) In re Zantac (Ranitidine) Products Liability Litigation, 2024 WL 3083342 (S.D. Fla. June 21, 2024) (judicial estoppel shot down plaintiffs attempting to renege on their agreements made earlier in the MDL to bring their claims solely in federal court; estoppel established all joinder of non-diverse defendants as fraudulent) (here) (20) Beaver v. Pfizer Inc., 2024 WL 234725 (W.D.N.C. Jan. 22, 2024) (favorable prescription drug preemption rulings barring straight-up stop selling, claims; pre-approval design defect allegations are also preempted stop-selling claims; design defect claim also failed on state-law grounds) (here).

But wait, there’s more.  Our 2024 collection of cases also features these near misses – another group of well-earned victories, all in federal district court, this time in reverse chronological order:

Lokkart v. Aziyo Biologics, Inc., 2024 WL 3057364 (C.D. Cal. May 29, 2024) (best of several opinions involving the same product that barred strict liability and warranty claims under state blood shield statutes) (here); Harris v. Medtronic Inc., 2024 WL 1747385 (D. Minn. April 3, 2024) (one-two punch of standing and preemption results in dismissal of recall-based class action) (here); Glover v. Avanos Medical, Inc., 2024 WL 1530685 (Mag. D. Or. March 19, 2024) (excluding plaintiffs’ engineering expert in broken device case, Oregon’s consumer expectation standard requires expert testimony in products cases involving complex medical issues, so summary judgment granted; however, the 2023 Rule 702 amendments were not followed), adopted, 2024 WL 1886375 (D. Or. April 29, 2024) (here); Avrin v. Mentor Worldwide LLC, 2024 WL 115672 (C.D. Cal. March 15, 2024) (rejecting “adulteration” as a basis for a parallel claim, and holding breast implant manufacturing defect claim expressly preempted) (here); In re Respironics Recalled CPAP, BI-Level PAP, & Mechanical Ventilator Products Litigation, 2024 WL 626100 (W.D. Pa. Feb. 14, 2024) (vacating most of a horrible special master’s report (2023-7) because the report violated Erie conservatism, as we had argued at the time; the parts left standing were bad enough to demote it to also-ran status) (here)

Looking to the future, 2025 should see the Second Circuit deciding (and hopefully applying) amended Rule 702 in the Acetaminophen (2023+4) MDL litigation.  Transfer was denied in Alcozar (2023+7), so that win is final.  Plaintiffs’ appeal in Klinker (2023+19) was dismissed.  Holley (2023-5) will stand or fall with what the California Supreme Court does with the pending appeal from Gilead Tenofovir (2024-1).  As we’ve already mentioned, both the lousy CPAP decision (2023-7) and the excellent Fosamax preemption decision (2022+5) have been reversed, or largely so.  Looking at older top and bottom ten lists, plaintiffs made the Zantac MDL so complex that they had trouble obtaining final orders, so appeals of the excellent rulings in that MDL (2022+4) (2021+10) (2021+18) still aren’t resolved.  The public nuisance claim in the City of Huntington case (2022+8) has been certified to the West Virginia Supreme Court of Appeals, where it remains pending.  We covered the Third Circuit affirmance of the Zostavax Lone Pine (2022+10) rulings above.  The Wilkins decision (2022+20) was affirmed in part and reversed in part in a split decision.

As we reported here and here, a case is pending in the United States Supreme Court that we expect will determine whether recovery of traditional personal injury economic damages − lost wages and medical expenses – can be considered “business or property” supporting civil RICO claims.  Another major matter with a pending appeal is the Muhammed learned intermediary case in the Illinois Supreme Court.  The Glover decision from this year’s near misses and the Paraquat Rule 702 decision mentioned at the beginning of this post are also on appeal.  Finally, the Michigan Supreme Court had the question whether to reaffirm the learned intermediary rule certified to it, but to our knowledge has not acted on that certification petition.

In summing up 2024, we would be remiss if we did not mention that the European Union adopted a new, unfortunately pro-plaintiff, “Product Liability Directive” that (among other things) applies strict liability not only to traditional goods, but also intangible goods and services and imposes the burden of proof on defendants to disprove both defect and causation.

Finally, we’re not aware of any pending national legislation with any significant chance of passage in 2025 that would impact on prescription medical product liability litigation.

See you in 2025.

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The District Judge in Lin v. Solta Medical, Inc. is evidently on a year-end push.  We reported just the other day on the court’s order granting summary on the plaintiff’s warnings-based claims, but denying summary judgment on design defect.  A few days later, the court ruled on the parties’ motions to exclude expert opinions.  This is quite the holiday treat, although the court’s order on experts delivers more lumps of coals for these parties than sugar plums.  On the whole, the defendant medical device manufacturer is probably looking forward to happier new year. 

To recap, a California resident traveled to Taiwan for cosmetic laser skin treatment and claims that she suffered second-degree burns as a result of the treatment.  The treating physician used the defendant’s device, so the plaintiff filed a product liability lawsuit—in California.  Each side filed motions to exclude expert opinions offered by the other side.  Lin, No. 21-cv-05062, 2024 WL 5199905 (N.D. Cal. Dec. 23, 2024). 

The outcome reflected a vigilant approach to the “gatekeeping” function mandated by the Rule 702.  Although the district court relied on Daubert and many older opinions, it is clear that the court applied the new rule, exemplified by the exclusion of several opinions in instances when earlier courts may have ruled incorrectly that objections “go to the weight.” 

How exactly did this play out?  First, the court granted the plaintiff’s motion to exclude most of the defendant’s medical expert’s opinions.  The parties in this lawsuit dispute whether the device used to treat the plaintiff was, in fact, an authentic device manufactured by this defendant.  Thus, the defense medical expert offered the opinions that the plaintiff had not established the authenticity of the device and that there was “no available evidence” that certain parts of the device were defective or counterfeit.  These opinions, however, were not based on any reliable methodology, but were instead based on the physician’s factual interpretation of deposition testimony.  The expert “simply characterized the state of the evidence,” which usurped the jury’s function.  Id. at *2-*3. 

The court also excluded the defense expert’s opinion that the treating physician breached the standard of care and caused the plaintiff’s alleged injuries.  The standard of care for physicians is determined by medical experts under similar circumstances, including geography in some cases.  Here, the defense expert could not address the standard of care in Taiwan, and he offered only general statements regarding “safety and efficacy” that were too value to be helpful.  The defendant’s medical expert will be allowed to opine on the plaintiff’s current condition and possible treatment options, and little else.  Id. at *3-*4.

Second, the defendant’s engineering experts were likewise limited.  The court excluded one engineer’s opinion that the device was safe because it was completely derivative of the fact that the FDA approved the product.  He offered no opinion based on his expertise or knowledge, and thus did not employ any reliable methodology.  The FDA’s review of the product “can be presented to the jury in a number of ways,” which would make the opinion redundant and unhelpful, too. 

The defendant’s engineers, however, will be allowed to rebut engineering opinions offered by the plaintiff.  These experts did not submit written reports, but because they were longtime employees of the defendant—and not retained experts—they did not have to.  Rule 26(1)(2)(B) requires a report from a witness “retained or specially employed to provide expert testimony,” which did not include witnesses “employed [by the defendant] for business purposes, not to regularly give expert testimony.”  Id. at *4-*5.

Third, the district court denied the defendant’s motion to exclude the plaintiff’s damages expert.  Sure, she assumed liability and was just doing arithmetic.  But experts (especially damages experts) are given assumptions all the time, and while she was performing mere arithmetic, it was “somewhat complex arithmetic.”  Id. at *5-*6.

Fourth, the court granted the defendant’s motion to exclude the plaintiff’s regulatory expert.  Because the court already granted summary judgment on the plaintiff’s warnings claims and on manufacturing defect, his testimony could not help the trier of fact and was irrelevant.  Id. at *6.  Given the mischief that plaintiff-side regulatory experts can cause, this is a good ruling. 

Fifth, the court largely gutted the plaintiff’s medical expert.  On causation, the expert could not describe a reliable methodology and could not describe what other causes she considered.  She agreed that she did not “consider other potential alternatives” or perform a “specific analysis” as to the cause of the plaintiff’s burn.  She agreed that the treating physician’s decision making contributed to the plaintiff’s outcome, but she did not consider potential malpractice as a contributing factor.  The plaintiff’s medical expert will be allowed to say that the treating physician was using the defendant’s device or a copycat device when the plaintiff was burned, and virtually nothing else.  Id. at *6-*9. 

The court also excluded the plaintiff’s medical expert’s opinion that the plaintiff’s burns were “most likely caused by” the defendant’s device, as opposed to a counterfeit device.  In forming this opinion, the expert was merely parroting the treating physician’s description of the device, which is not a reliable methodology.  The other purported bases for her opinion were equally unreliable, nothing more than ipse dixit, and statements with “no indication at all as to what information supports that conclusion.”  Id. at *9-*11.  The medical expert’s opinions on the adequacy of the warnings, the defendant’s purported “failure to train,” and an earlier version of the device were irrelevant and unhelpful; and her opinions on the defendant’s “knowledge and intent” were similarly irrelevant, but also “pure speculation” with “no methodical basis.”  Id. at *11-*12. 

Sixth, the court also largely gutted the plaintiff’s engineering expert.  His testimony on how the device works was not an expert opinion, and he was not qualified to offer opinions on design alternatives.  The expert had worked in research and development in the medical device industry and had experience with wound closure and cardiac devices.  But he never used the device at issue here, or even seen one before consulting with another of plaintiff’s experts for this litigation.  He admitted that he “did not quite understand the magic” of one device and that he has “no expert knowledge concerning the relevant market, how competing products are designed, how those design features work, and what tradeoffs they entail.”  The expert was likewise not qualified to offer opinions on “preferred safety features” and “displayed warnings” for the device, since “[h]e is an engineer, not a physician.”  Id. at *13-*14. 

The court also excluded the plaintiff’s engineering expert’s opinions that it would be difficult to make a counterfeit device and that the device warnings were not adequate because the court was “unable to determine what method [the expert] even claims to use,” leaving the court “unable to discern any basis for finding that the opinions are reliable or trustworthy.”  And, of course, having granted summary judgment on warnings, opinions on the warnings were unhelpful and irrelevant, too.  Finally, the court excluded the engineer’s opinion that physicians have a financial incentive to work quickly.  Talk about ending with a whimper.  Id. at *15-*16. 

As we said at the top, this order shows the hallmarks of the new Rule 702 in a couple of ways.  The court clearly placed the burden of demonstrating admissibility on the party offering the opinions, and the court applied that burden evenhandedly going both ways.  Moreover, rather than defaulting to the mantra that objections “go to the weight,” the court excluded opinion where qualifications or methodology was lacking.  Another judge might have ruled improperly that an expert’s experience with other medical devices went “to the weight.”  This judge excluded the opinions.  Same with a causation methodology that failed to consider alternative causes.  This judge excluded the causation opinions.  Both sides took their lumps, but we think the defendant came out better here. 

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May the holidays treat you well.  We trust that none of you got burnt by any of the many hot things loitering around this time of year: yule logs, candles, figgy puddings, overloaded electrical outlets, and Aunt Sally’s line dancing after she downs a third eggnog. 

Today’s case is not exactly hot, but it’s got enough good bits to warm our flinty, defense-hack hearts. It’s like a two-fer present under the tree, with one present being considerably more fun than the other. Think of unwrapping a box that ends up containing a bottle of scotch and a pair of socks. Lin v. Solta Med., Inc., 2021 U.S. Dist. LEXIS  228901 (N.D. Cal. Dec. 18, 2024), is a to-be-published decision granting summary judgment against warning claims in a long-running product liability case. The plaintiff claimed that she got burned by a bad product.  But it was her case that got burned by a straightforward application of California’s learned intermediary rule.

 The plaintiff, a California resident, had gone abroad to obtain a cosmetic surgical laser skin treatment that was apparently not available in the US (probably for FDA reasons).  She claimed injury in the form of second degree burns and blamed the medical devices used.  She filed a complaint in Alameda County (the darling of plaintiff lawyers) alleging the usual litany of product liability claims (failure to warn, design defect, manufacturing defect, and breach of warranties) against a couple of companies.  The case was removed to federal court. One defendant got out on jurisdictional grounds.  One did not.  The California manufacturer remaining in the case filed a motion for summary judgment.  The plaintiff punted on the manufacturing defect and warranty claims. What was left was a phalanx of warning and design defect claims (in both strict liability and negligence versions). The defendant won on warning but lost on design defect.

As a preliminary matter, the Lin court applied California law.  Why?  The medical procedure took place in Taiwan.  Be that as it may, the court applied California law.  Maybe the parties agreed.  Maybe Taiwan’s law is similar (though that would surprise us – Taiwan seems pretty smart about most things).  We bet the federal judge was happy not to have to undertake an exploration of Taiwanese tort law.

The court applied the learned intermediary rule to the warning claims.  Following a nicely reasoned analysis, the court held that the warning was adequate as a matter of law and there was no warning causation.  The treatment involved general anesthesia, which increased the risk of burns (because a patient under general anesthesia is less sensitive to pain and less able to alert the treaters) and the successive use of two different devices, which also increased the risk. The plaintiff argued that the device manual was unduly vague about these risks, but the undisputed record showed that the plaintiff’s doctor knew them. The treater was not only aware of the relevant risks, but had the plaintiff sign a consent form reciting them. Moreover, it was the doctor, not the defendant, who was responsible for the dual use. 

The court rejected the claim that the defendant had a duty to warn “specifically about greater risk when a different medical device is also used. The duty to warn about the “enhanced” risk when also using a different product was “too much” because it proposed that a “defendant must warn with specificity about every conceivable element that might” increase an already warned-of risk.

The best part of the Lin court’s opinion is its conclusion that the plaintiff’s theory was, in practicality,  that “any warning short of a complete contraindication or ban is insufficient as a matter of law.” That often ends up being the theory in most of our failure to warn cases.  What is wanted is not a warning that would truly help a doctor weigh risks; rather, the plaintiff wants a ‘warning” that essentially says, “Don’t use this product.”  The Lin court held that the plaintiff’s theory “would require the jury to go beyond what is permitted by California law and find that a defendant must not only inform but also explicitly limit the usage of a product, thereby eliminating the consumer’s option to ‘avoid the danger by careful use.'” Adios, warning claims.  Summary judgment was granted. 

By contrast, the design defect analysis did not quite go the manufacturer’s way. The manufacturer did get its way by persuading the court to apply the risk-benefit test, as opposed to the consumer expectation test. The Lin court reasoned that the consumer expectation test for design defect was not applicable to a prescription-only medical device that is used only by specialized physicians. Such devices are beyond the understanding or expectations of lay jurors. So far so good. But the Lin court denied summary judgment on risk/utility because defendant did not adequately address factors other than the relative rarity of this adverse event and its warnings.  To be sure, the defendant had a strong point that the actual rate of adverse event reports of product involvement with burns was approximately 0.007% of treatments. But the court concluded that the jury could look to other factors, such as feasibility and cost of the plaintiff’s proposed safer alternative design, in considering the negligence and strict liability design claims. 

It is possible that those other factors will end up working out in the defendant’s favor. For example, the strict liability design defect claim should fail because California law does not permit strict liability design claims against prescription products.  It’s just going to take more litigation to get there. Sometimes the best presents do not show up until after the New Year.

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The decision in Burton v. AbbVie, Inc., 2024 WL 3207008 (C.D. Cal. Feb. 21, 2024), presented an interesting, if somewhat arcane, discovery question:  whether a plaintiff’s treating physician, listed as only an “un-retained” percipient witness for which no expert report is required under Fed. R. Civ. P. 26(a)(2)(C), can be deposed during the period of time that a court’s scheduling order provides solely for “expert” discovery.  Burton held that was proper under the rules:

Plaintiff’s disclosure of [several treaters] as non-retained experts . . . cuts against her argument that these doctors are only percipient witnesses.  Furthermore, while Plaintiff asserts that the treating physicians will only testify to treatment given in the past and what may be needed in the future, the Court notes that this testimony will inherently require the physicians to rely on their medical training to opine on what future treatment may be needed.  Accordingly, this Court joins the other district courts in this circuit to find that a treating physician, by virtue of their training and skill, is also properly considered an expert witness.  Therefore, Defendants are free to depose [the treaters] during expert discovery.

2024 WL 3207008, at *3 (no citations omitted) (emphasis added).  Plaintiff offered “no authority” for her contrary argument, and the “handful of unpublished cases” the defendant cited are not mentioned in the Burton opinion.  So we decided to take a look.

Continue Reading Treating Physicians May Be Deposed as Experts
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We warned everyone, but there is no sense beating a dead horse (or bear, or whale).  So we’re getting right to the unpleasant business of discussing the bottom ten worst prescription medical product liability litigation decisions of 2024.  And we stress both “product liability” and “litigation.”  Otherwise, we’d have to include Harrington v. Purdue Pharma L.P., 144 S. Ct. 2071 (2024), concerning the scope of bankruptcy releases in a pharmaceutical mass-tort driven Chapter 11 proceeding.  While we discussed Harrington here, as defense lawyers we find something abhorrent about considering a defendant’s bankruptcy as part and parcel of prescription medical product liability litigation.  Other non-prescription medical product cases that we consider both important and adverse include Davidson v. Sprout Foods, Inc., 106 F.4th 842 (9th Cir. 2024), perpetuating the fiction that a state’s in toto mass adoption of FDCA standards makes their enforcement “state law” for preemption purposes (here); Carson v. Monsanto Co., 92 F.4th 980 (11th Cir. 2024), another adverse preemption decision that we discussed here; and In re Natera Prenatal Testing Litigation, 664 F. Supp.3d 995, 1007-08 (N.D. Cal. 2023), predicting (contrary to Erie principles) a consumer protection exception to the learned intermediary rule (here).

Even without obnoxious decisions like those, there’s more than enough judicial road kill and brain worms out there to complete our disagreeable task of compiling the ten worst prescription medical product liability decisions of the year.  We’ve been shoveling the Augean Stables of prescription medical product liability litigation since 2007, assembling this annual list, because who else would do it if we didn’t?  Bad decisions, like good ones, should be recognized as such.  While it’s always possible that an eleventh-hour holiday horror could arise, as happened here and here, late-breaking adverse precedent has so far been thankfully uncommon.

That’s enough prologue.  On to the agony.  Coming up are ten decisions that make us say “ow, ow, ow” rather than “ho, ho, ho.”  If you were on the receiving end of any of these bad boys, believe us, we sympathize since our own cases have made this list before (see, e.g., 2013-2 and 2021-10).  Just keep up the good fight.  Lawyers that never lose aren’t trusted with difficult cases.  Keep in mind that the pain will go away, since next week we’ll be heralding the top ten best decisions of 2024.

  1. Gilead Tenofovir Cases, 317 Cal. Rptr.3d 133 (Cal. App. 2024).  Our worst case of the year recognized a pernicious “negligence” theory that created liability for the makers of non-defective drugs for not inventing and obtaining FDA approval of different, allegedly “safer” drugs for the same indication.  Moreover, it did so in the context of drugs that reduced a diagnosis of AIDS from a death sentence to merely a chronic condition.  For those with short memories, before the drug at suit, people were dying of AIDS by the thousands.  Tenofovir now holds that its manufacturer can be liable for getting that drug through FDA approval, instead of one not approved until a decade or so later.  We can’t imagine how many more people would have died in misery had that been the law at the time.  And no state suffered more from the AIDS epidemic than California – talk about biting the hand the feeds (saves) you.  Strict liability was a California invention that made proof of a “defective” product easier than negligence.  An intermediate appellate panel has stood the law on its head, holding that negligence can impose liability “beyond the duty not to market a defective product.”  Tenofovir relied chiefly on a case involving chicken bones in food, rather than California’s extensive precedent involving prescription medical products. We see no way that Tenofovir can possibly be squared with solicitude that the California Supreme Court showed for prescription products in the 1988 Brown case that abolished strict design defect liability for such products.  Now no defect is required at all, only “foreseeability” that a later, safer drug would have been approved by the FDA.  On a clear day, in California, courts (at least this one) can foresee forever.  The decision’s public policy analysis is exemplified by this quotation:  “[m]oral blame is typically found when the defendant benefits financially from its conduct.”  Making a profit is thus declared immoral in California.  This novel “duty to innovate” will do just the opposite – affirmatively impede innovation on both ends of the product cycle.  Liability is a form of deterrence, and the liability recognized in Tenofovir will deter product innovation on both ends.  At the front end, it deters manufacturers fearful of liability from bringing any “first in its class” product to market, since some later related product might, in hindsight (in Tenovofir, two decades after the fact), turn out possibly to be “safer” for some patients in some respect.  On the back end, the same liability will deter manufacturers from releasing improvements that make their products “safer,” because doing so could create hindsight liability for all sales of the original product for whatever injuries the “safer” innovation arguably could have provided.  As of now, any defendant who “knows” of an allegedly safer and equally effective design for a product it currently makes will be compelled to replace its existing, non-defective product with the alternative design, or else face a risk of broad liability.  Thankfully, the California Supreme Court will review.  We trashed Tenovofir here, and tore into it again here.
  2. In re Fosamax (Alendronate Sodium) Products Liability Litigation, 118 F.4th 322 (3d Cir. 2024).  This is the second time that a Third Circuit reversal of a preemption summary judgment holding in the Fosamax MDL has earned the dubious distinction of landing high on our annual worst of the worst list (2017-1).  The first Fosamax decision, among other things, found that preemption was a jury question.  That decision was unanimously reversed by the Supreme Court in Albrecht (2019+1) and remanded for the trial court to rule on preemption as a matter of law.  The trial court did, reviewing a long and detailed FDA administrative record, including the FDA’s view of that record as briefed in the Supreme Court, and once again found preemption (2022+5).  Once again, however, the Third Circuit reversed, and its new opinion is equally bizarre.  We’ve always thought of the adversary litigation process as an effective way to uncover the truth.  This Fosamax opinion utilizes a presumption against preemption – increasingly endangered everywhere else – as a means of avoiding the truth.  Fosamax effectively thumbed its judicial nose at the Supreme Court’s Albrecht holding, this time putting said thumb on the scale through that presumption rather than, as in the first time around, through a heightened burden of proof.  The Supreme Court held that subsidiary facts relating to the legal question of preemption are determined by the court.  That meant a “clearly erroneous” appellate standard of review, which the Third Circuit first recognized, and then disregarded, using the same presumption as grounds for reversal.  Further mischaracterizing the Supreme Court’s decision, the Third Circuit panel described it as “emphatically” applying the presumption against preemption, when in fact the opposite was true.  No such presumption is mentioned anywhere in Albrecht. Rather, the Supreme Court spent several pages reformulating its earlier Levine decision, pointedly removing all references to that presumption, which had been so prominent in Levine.  Having utterly misconstrued Albrecht, the Third Circuit then wielded the presumption against preemption as a sword to cut off, and thus reverse, the district court’s detailed analysis of the FDA’s administrative record.  Using the presumption to evade the “clearly erroneous” standard of review, Fosamax held that reliance on the administrative record was simply unnecessary.  If the FDA’s formal determinations were “ambiguous” so as to warrant review of this record, the presumption required an anti-preemption result, notwithstanding anything that the FDA had actually done, and even contrary to what the agency had told the Supreme Court it had done in its amicus brief in Albrecht.  Thus, instead of using a presumption to simplify the fact-finding process, or to fill in blanks (why presumptions exist in the first place), Fosamax used the presumption to avoid looking at the FDA’s administrative record at all.  The presumption controls and actual facts be damned.  Fosamax even disinterred an old Supreme Court chestnut from a non-FDCA field preemption case, the courts “have a duty to accept the reading that disfavors pre-emption.”  Fosamax concluded by telling FDA-regulated defendants’ tough luck, since the FDA can “take its time” but defendants must “at all times” be held responsible for their labeling, whether the FDA would let them change it or not.  That, of course is completely at odds with the Mensing (2011+1) independence principle, but Fosamax also gave Mensing the back of its hand, because generic cases are “different.”  They are not, of course, when implied preemption is at issue, but since Fosamax had already disregarded Albrecht, why stop there?  We flogged the blatantly result-oriented opinion in Fosamax here and here.
  3. Himes v. Somatics, LLC, 549 P.3d 916 (Cal. 2024).  In Himes, the highest court of the largest state in the country upset decades of settled precedent concerning learned intermediary causation, and embraced the very dubious factual proposition that, despite their physicians’ recommendations, some mythical “objective” patient would refuse to follow medical advice had a prescription medical product’s labeling said more about whatever risk that became reality to any particular plaintiff.  One of the primary bases for having the learned intermediary rule in the first place is to protect and preserve the physician-patient relationship, so historically plaintiffs failed to establish warning causation as a matter of law where the prescriber would still have prescribed the medication/device notwithstanding whatever aspect of the warning was at issue.  To allow causation theories premised on patient rejection of physician recommended prescriptions is inherently destructive of the physician-patient relationship.  At least the court did not accept the extreme plaintiff position that a plaintiff with dollar signs in his/her eyes could establish a jury submissible causation case with nothing more than their own self-interested testimony that, in hindsight, s/he would have rejected the product “had I only known.”  But the standard that Himes adopted, that “a plaintiff may establish causation by showing that the physician would have communicated the stronger warning to the patient and an objectively prudent person in the patient’s position would have thereafter declined the treatment,” is novel, relies on multiple hypotheticals, and invites speculation on numerous levels.  Consequently, the proposition will be quite difficult definitively to rule in or out, meaning a lot of denied summary judgment motions.  The Himes test is one of those propositions that sounds nice as an academic matter, until one considers issues of proof.  How does one establish how a theoretical “objectively prudent” patient would have behaved?  Does this become yet another field for paid experts to offer predictable paid opinions?  Conversely, with the door open for plaintiffs to argue that their physicians’ advice should have been ignored, it would appear that discovery into how the plaintiff reacted to other warnings concerning other products is now relevant, since defendants are entitled to challenge the credibility of “if I had only known” testimony.  Claims based on refusing prescriptions also tend to devolve into preempted “stop selling” claims, since holding that an extra couple of percent of a serious risk satisfies the Himes standard amounts to a determination that all (or the great bulk of plaintiff-patients) should never have had the treatment at issue.  However these proof issues play out, the purpose and intent of the change is to reduce the availability of summary judgment in warning causation cases.  Himes offered a long list of relevant, but not dispositive “factors” to consider.  The only thing that is certain after Himes is that prescription medical product liability litigation in California will be still more expensive and time-consuming.  We harped on how horrible Himes was here.
  4. Providence Health System-Oregon v. Brown, 548 P.3d 817 (Or. 2024).  The vast majority of precedent, which we discussed in this somewhat dated 50-state survey, rejects holding hospitals strictly liable as “sellers” of products.  Indeed, as that post indicates, the trend had been against hospital strict liability, with several states that had initially allowed it changing their minds.  Not so in Oregon.  Ignoring – literally − a decades-long trend, Providence Health held that nothing after 1979 (before Illinois and Missouri switched sides) could even be considered.  Why?  Because Oregon adopted Restatement §402A by statute in 1979.  Thus, in construing the legislature’s intent in adopting the relevant sections of §402A, which are vague and capable of multiple meanings, nothing after 1979 was relevant.  Having made 45 years of interpretive precedent vanish by legal fiat, Providence Health was free to expand liability because that was what §402A in general was intended (when drafted in 1965) to do.  Thus, hospitals in Oregon are now strictly liable as “sellers” of prescription medical products administered in the course of medical treatment.  The decision even ignores subsequent hospital-specific legislation for the same reason.  That is a very disturbing proposition on a number of levels, since much has happened in the product liability field since the year before Bexis started law school.  As the Oregon product liability statute covers a lot of areas, including adoption of most the §402A’s comments, this holding could well put Oregon law in a similar time warp, unable to consider the last 45 years of precedent, on any number of product liability issues.  Indeed, we’ve already commented on a similar problem with the learned intermediary rule in Oregon, arising from the same vague statutory section and the same refusal to consider product liability as it is, and not as it was 45 years ago.  For artificially creating a legal vacuum, and then filling it with expansive strict liability, Providence Health ranks high on our worst decision list.  We pummeled Providence Health here.
  5. This entry is from neither the Reed Smith nor the Dechert sides of the Blog.  In re Zantac (Ranitidine) Litigation, 2024 WL 2812168 (Del. Super. June 3, 2024) (“Ranitidine”).  Delaware claims itself to be the legal home of more than a million business entities, including more than two thirds of Fortune 500 companies.  This is in no small part because Delaware has become known as a place where corporations can receive reasonable, fair-minded treatment in court.  This Ranitidine decision, allowing junk science into evidence in a coordinated proceeding of nearly 75,000 cases, threatens the First State’s good reputation.  Over the course of over 300 pages, the trial court adopted virtually every pro-plaintiff position that the federal Zantac MDL (2022+4) rejected when it refused to admit the same theories under the nearly identical federal Rule 702. It’s hard to know where to begin on all the ways that Ranitidine got it wrong, which is why it qualifies as the worst trial court decision (state or federal) of 2024.  The decision permitted unscientific testing, cherry-picked data, litigation-driven reasoning, and plain sloppy science − all based on the outdated and incorrect premise that these challenges merely speak to “weight not admissibility.”  But we have to say that most troubling were the rulings that cut across all experts.  First, Ranitidine permitted general causation opinions based on studies relating to whether NDMA − as opposed to ranitidine, the active ingredient in the defendants’ drugs − causes cancer.  That assumes what the plaintiffs’ experts opine, since NDMA is known to be carcinogenic.  However, no reliable scientific evidence exists to establish that ranitidine has that property.  Second, Zantac failed to require that the plaintiffs’ experts identify any sort of “threshold dose,” that is, the minimum dose where any harm can occur. This is fundamental scientific fallacy, and threshold dose is absolutely critical in a litigation like this, where the substance NDMA is found in air, water, and all manner of foods without causing cancer.  The trial court’s reasoning is exactly the sort that the federal Rule 702 amendments were designed to prevent.  The silver lining is that this opinion was so bad that, since our prior post on this case, the Delaware Supreme Court has done something it rarely does, and has accepted the defendants’ interlocutory appeal.  We hope that court will right this wrong and we’ll see it on next year’s 10 best list.  Some of us rebuked Ranitidine here.
  6. Huertas v. Bayer US LLC, ___ F.4th ___, 2024 WL 4703136 (3d Cir. Nov. 7, 2024).  In 2018, the Third Circuit, in a non-prescription medical product decision, rejected standing for product liability plaintiffs seeking money for nothing – alleging only that they didn’t know that the product, which they had used successfully and without any injury or risk of injury, had a concealed carcinogenic contaminant.  That decision held that “buyer’s remorse, without more, is not a cognizable injury,” and denied standing.  Fast forward six years, and Huertas, reversed dismissal of a factually indistinguishable (also involving carcinogen allegations) no-injury class action against a recalled OTC drug on one of the flimsiest attempts at distinguishing otherwise controlling precedent that we’ve ever seen.  The basis of Huertas’ distinction was that, while the prior plaintiffs had not pleaded that the product was “defective,” while the Huertas plaintiff did.  The contaminant in the prior, controlling case was asbestos, however, which under New Jersey law, which Huertas purported to apply, has been held in scores of decisions to be a product defect.  Moreover, easily correctable pleading deficiencies played no part in the reasoning of the prior controlling case.  What mattered in that case, as in Huertas, was the plaintiff class pleaded no purported damages beyond buyer’s remorse.  The Huertas class’ purported damages amounted to, at most, not using a single partial tube of an OTC fungicide.  Huertas thus thumbed its nose at both controlling precedent and the fundamental precept that de minimis non curat lex.  But for some silver linings, Huertas could have ranked higher (lower?) on today’s list.  We heckled Huertas here.
  7. Herzog v. Superior Court, 321 Cal. Rptr.3d 93 (Cal. App. 2024), review denied (Cal. Aug. 28, 2024).  A decision we cannot discuss.
  8. In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2024 WL 776757 (D.N.J. Feb. 26, 2024).  If it’s Valsartan, you know it has to be bad.  This benighted MDL has previously generated decisions that “graced” our worst of lists for three of the last four years (2023-1, 2021-4, 2020-10) so why should 2024 be any different?  Unfortunately, it’s not, and thus Valsartan breaks a tie and holds the record for most negative appearances on our year-end lists.  Certified product liability class actions have been rarer than hen’s teeth in recent years, but last year’s worst case of all certified no fewer than four of them in one fell swoop with the express intent of forcing the defendants to settle.  Not surprisingly the defendants sought an interlocutory appeal, but unfortunately the Third Circuit denied the petition without explanation.  Subsequent activity uncovered additional grounds (questionable damages experts and unsavory would-be class representatives) why these unprecedented classes should never have been certified, so the defendants moved to decertify.  In denying that motion, Valsartan did something else unprecedented – it asserted that the Third Circuit’s summary order was an “affirmation” of the aforesaid class certifications.  But law of the case doesn’t work that way.  A previous appeal must actually be decided on the merits to be law of the case.  Such a ruling was doubly inappropriate in the class certification context, given that Fed. R. Civ. P. 23(c)(1)(C) expressly provides that “[a]n order that grants or denies class certification may be altered or amended before final judgment.”  The class certification order itself was our worst decision of last year, and for giving a facially invalid reason for refusing to reconsider that order, this year’s Valsartan decision makes this year’s list.  We vented about Valsartan here.
  9. Dressen v. AstraZeneca AB, 2024 WL 4666577 (D. Utah Nov. 4, 2024).  The Public Readiness & Emergency Preparedness (“PREP”) Act was written by Congress to facilitate the emergency production of so-called “covered countermeasures” – including vaccines − during public emergencies.  Among other things, the PREP Act was designed to overcome fears of product liability by those asked to manufacture experimental anti-pandemic products at breakneck speed.  Thus, the PREP Act has the most extensive language precluding state (or federal) liability that we have seen in any statute anywhere, including both preemptive and immunity language.  As our PREP Act scorecard demonstrates, until Dressen, no PREP Act-protected vaccine manufacturer had ever lost a dismissal motion in a personal injury case.  Plaintiff claimed that the defendant had violated “contractual” language in the informed consent agreement that she signed when she received the defendant’s vaccine.  However, the language allegedly concerned reimbursement for medical expenses and personal injuries.  So it was really a tort claim poorly disguised as a contract claim.  Even that shouldn’t have mattered, because the broad statutory preemption and immunity language made no distinction between tort and contract claims.  Rather, preclusion of liability turned on whether the “countermeasure” had been “prescribed,” “dispensed,” or “administered,” all of which indisputably occurred in Dressen.  Thus, the claims in Dressen were all within the express terms of the PREP Act’s preemption and immunity language.  So Dressen simply ignored what the statute stated and relied on cases involving would-be “countermeasures” that, due to one defect or another, were never actually administered to anyone.  Then Dressen asserted that the plaintiff’s damages – all personal injury related – were “caused” by the claimed breach of contact rather than the vaccine.  But the but for cause had to be the vaccine’s administration, since without that, the plaintiff’s alleged damages would not have happened.  As a backup, Dressen claimed the statute’s broad preemption language was “absurd,” because without the allegedly breached contract, people would be deterred from getting experimental vaccines, which was supposedly contrary to the basic purpose of the PREP Act.  The only thing “absurd” about Dressen was that rationale.  Nearly 270 million Americans received experimental COVID-19 vaccines authorized under the PREP Act.  Almost none of them had any contract of the sort alleged in Dressen.  They received these vaccines because it was their best available medication for avoiding COVID-19, which killed well over a million Americans.  Finally, the PREP Act did not render any contractual provision “illusory,” as Dressen repeatedly stated.  That plaintiff had the same ultimate recourse that every other vaccinated American had, which was the Countermeasures Injury Compensation Program that the PREP Act also created.  Dressen is an example of spherical error; it is wrong anyway one views it.  We deconstructed Dressen here.
  10. Ahmed v. Johnson & Johnson Healthcare Systems, Inc., 2024 WL 693078 (S.D. Ala. Feb. 20, 2024), reconsideration & certification denied, 2024 WL 947447 (S.D. Ala. March 5, 2024).  Ahmed takes the last spot on our bottom ten list because it bizarrely allowed a plaintiff claiming injury from an implanted medical device to get away with having no medical expert, yet still avoid summary judgment on causation.  Ahmed was contrary to Alabama law as stated by both the Alabama Supreme Court, generally, and the Eleventh Circuit (and a half dozen district court decisions), in the specific context of prescription medical product liability litigation.  It was not that the plaintiff in Ahmed did not think about getting medical testimony.  Plaintiff simply failed to call the medical expert she had lined up, who was listed only as a “rebuttal witness.”  So plaintiff avoided summary judgment, despite bearing the burden of proof, without any medical testimony at all – in a case involving the alleged cause of the breakage of a metal weight-bearing implant.  Ahmed let plaintiff skate on basic medical causation point by holding that a broken device case wasn’t  “complex.”  But Ahmed cited nothing for that remarkable conclusion, only distinguishing the defendant’s authority.  The jury, unguided by any affirmative medical testimony could conclude “that the damages over which Plaintiff sues resulted from the [implant’s] failure and not some alternate cause.”  Why?  Pure “temporal relationship.”  That’s just wrong under controlling Eleventh Circuit precedent, and even under the cases that Ahmed cited.  And it’s loud wrong, too, as the defendant’s motions for reconsideration and certification were both denied.  We abhorred Ahmed here.

Finally, we’re done, and not a moment too soon.  Now that we’ve finished with this judicial roadkill, and recovered from excessive exposure to jurisprudential brain worms, we’ll move on to something much more pleasant – our discussion, next week, of the top ten best drug/device decisions of 2024.

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It’s the holiday season, and we’re getting in the festive spirit. We like old-school jingle in our jangle (even though that’s not necessarily holiday themed), more recent, unquestionably holiday-focused jingle jangle, and even first-gift of Christmas jingle,  But there may be nothing more festive than a rock-solid preemption win—particularly one from California. We think this one will put a spring in your step and a sparkle in your smile.  

Continue Reading Jingle Jangle, California OTC Preemption
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This is from the Holland & Knight side of the Blog only.

If you have followed the Blog, then you will know that we have long touted the importance of Erie deference by federal courts sitting in diversity.  We have also questioned the expansion of tort law to allow governmental entities to use public nuisance to shift the costs of governmental services to private entities without calling it a tax.  We have even discussed the issue of abrogation of common law claims, which can be seen as a lingering source of unchecked liability, when a state enacts a product liability act.  For various reasons, however, we have largely declined to comment on the use of public nuisance as the primary theory for governmental entities as plaintiffs in opioid litigation.  Today’s post is an exception, and it deals with a pretty significant decision, which we think is overdue.

Continue Reading Ohio Does Not Recognize Public Nuisance Claims For Products
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It might seem that we talk about preemption incessantly on this blog, but a pretty good opinion from a pretty important jurisdiction went unremarked by us last September. We’ll rectify that right now. Call it an end of year clean up session.

The decision in Howard v. Alchemee, LLC, 2024 U.S. Dist. LEXIS 169359 (C.D. Cal. Sept. 20, 20240, actually addresses three California no-injury class actions alleging that certain over the counter (OTC) acne medicines were contaminated with carcinogenic benzene.  The plaintiffs claimed that the manufacturers failed to warn that the active ingredient (BPO) in their acne products degrades into benzene under normal use, handling, and storage conditions.  The plaintiffs did not allege any specific adverse events from benzene.  They simply wanted their money back.  

By the way, guess who says they found the benzene in the products?  It was that good, old “independent” lab, Valisure — which proceeded to file a citizen’s petition with the FDA seeking action against BPO products.  Sound familiar?

The defendants filed a motion to dismiss, based on lack of standing and on preemption.  The former argument got rid of the request for an injunction, but not the request for money. 

The latter argument was more successful.  The court dismissed the actions with prejudice because they were expressly preempted by federal law.  The “broad” OTC preemption clause precludes any claims that would have state law establish any requirement “that is different from or in addition to, or that is otherwise not identical with, a requirement under” the Food, Drug, and Cosmetics Act (FDCA).  OTC acne drugs are governed by a Food and Drug Administration (FDA) monograph.  The monograph expressly permits BPO in specified amounts.  Compliance with the monograph means the product is “generally recognized as safe” (GRAS) and not misbranded. Thus, the plaintiffs’ claims are “fundamentally at odds” with the monograph for these products. 

Further, the plaintiffs in these actions did not allege anything about the particular products they used. They cited no testing of their products.  (This seems to be a theme in cases involving Valisure.) Essentially, the plaintiffs suggested that all BPO products contain benzene.  The court interpreted the plaintiffs’ position as not  “genuinely seeking a warning that the product unsafe – which would be stark enough – but rather are pursuing a ban on selling what they believe is an ‘adulterated,’ illegal product.” The plaintiffs’ claims were an attack on the FDA’s GRAS findings and constituted an attempt to make state law ban the defendants’ products.   

The plaintiffs attempted to disclaim any beef with the FDA by suggesting that the FDA was ignorant of BPO’s dangers.  But the plaintiffs’ complaint was replete with allegations “that the scientific community has known of BPO’s degradation into benzene for almost 90 years.”  Sometimes plaintiff story-telling comes back to hurt them.  The Howard court also cites Ninth Circuit authority noting the “scientific expertise of the FDA.”

In addition, there was a fatal flaw in the plaintiffs’ demand that benzene be disclosed on the product labels.  Benzene does not fit the definition of an active or inactive ingredient.  It is not a “purposefully added component of the drug.”  Put simply, breakdown products are not disclosable under the FDCA.

The plaintiffs attempted to borrow the parallel claim exception from medical device law, even though such borrowing is generally questionable and the plaintiffs could not specifically find a parallel to a FDA requirement. First, there was no true parallel to the FDCA’s general misbranding provision because the monograph deals with ingredients specifically, and the plaintiffs did not claim any violation of the monograph. In any event, omitting a warning not required by the FDA cannot equal misbranding.  Without a specific, affirmative violation of misbranding provisions, the misbranding notion as a generality cannot support a parallel claim.  Second, the plaintiffs’ claim cannot add up to a parallel violation of “adulteration.”  State laws prohibiting misleading advertisements on which the plaintiffs relied on these cases are not parallel or identical to the FDCA’s prohibition against selling adulterated drugs. 

In sum, the plaintiffs endeavored to force the acne medicine manufacturers to make disclosures that would conflict with the FDA’s determination that BPO was safe and effective.  Because the plaintiffs’ claims “would impose requirements that differ from and are in addition to those on the FDCA, they are preempted.”

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Is the question we are asking ourselves after reading Butler v. 3M Company, 2024 WL 5054884 (S.D. Ohio Dec. 9, 2024).  Because if plaintiffs get to amend their complaints post-remand to add whole new claims and allegations, then the MDL process of litigating based on a master complaint doesn’t seem to make a lot of sense, or create the efficiencies attributed to it.

Butler is a case from the Bair Hugger MDL in which plaintiffs alleged that defendants’ patient warming devices purportedly caused joint infections during surgery.  The Master Long Form and Short Form complaints in that MDL have been on file since 2016.  Plaintiffs filing suit after that date, like Ms. Butler, could file a short form complaint providing certain case-specific information, but essentially adopting the allegations of the long form complaint.  Such plaintiffs were also given the right to file amended complaints, “upon the showing required by the relevant Federal Rules of Civil Procedure.”  Id. at *1.  Which became a key issue in Butler—what rule applied to plaintiff seeking to amend her complaint post-remand.

Where a plaintiff moves to amend her complaint before the deadline to do so, Federal Rule of Civil Procedure 15(a)(2) provides that “[t]he court should freely give leave when justice so requires.”  But, if the deadline has lapsed, Rule 15’s liberal policy yields to the higher threshold for modifying a scheduling order found in Rule 16.  In this case, the plaintiff must “show good cause” for not seeking leave before the deadline before the court will consider whether the amendment is proper under Rule 15.  Id. at *2. 

Butler was one of 28 cases remanded or transferred from the MDL to their home districts for trial.  The remand court entered a scheduling order setting a deadline for filing motions to amend pleadings.  Plaintiff moved to amend before expiration of that deadline, but long after the pleadings deadline in the MDL—creating a Rule 15 versus Rule 16 conundrum.   Now, if Butler was the only case addressing this issue it may not be a big deal. But the Butler court acknowledged that “several” remand courts were being asked to allow plaintiffs to amend their complaints.  Id. at *3.  Including the MDL court itself in an individual case:

 the MDL court concluded … that “any present motion to amend a complaint in this MDL is governed by Rule 16” and that “[p]laintiffs in the MDL seeking to amend a complaint after July 29, 2016 must proceed under Rule 16 and its good cause standard.”

Id.  Seems hardly open to debate.    

But the Butler court chose to “asum[e] without deciding” that Rule 16 applied and concluded that plaintiff demonstrate good cause based on some suspect reasoning.  Such as, that plaintiff filed her motion to amend before the deadline set by the remand court.  But that’s like saying she met Rule 16’s threshold because Rule 16 doesn’t really apply.  More importantly, the court was persuaded to find good cause because “bellwether trials are designed to, among other things, test different claims and litigation strategies.”  Id. at *4. And plaintiff is “entitled to select which to assert in her own case.”  Id.  No doubt she is.  The same can be said of every plaintiff.  That is the whole point of the short form, case-specific, complaint.  That is the vehicle in which a plaintiff identifies which specific claims she is pursuing.  That plaintiff is entitled to select her claims has nothing to do with whether plaintiff acted diligently in making that selection.  This type of reasoning is an open invitation to any remanded plaintiff to cast off the centralized pleadings of the MDL.  As defendants in Butler argued, amended pleadings at this stage are also likely to re-open discovery, further diminishing the efficiency MDLs are meant to create. That this plaintiff was a late filer in the MDL should have cut against allowing an amendment rather than in favor.  Her counsel had the benefit of all of the proceedings and the discovery in the MDL at the time her complaint was filed and could have added whatever allegations she wanted at the time of filing, or certainly shortly thereafter and in any case, before remand.  She did not. 

Substantively, while the amendment is being allowed, the court ruled it was futile to add claims under Minnesota law where plaintiff is an Ohio resident who was allegedly injured in Ohio.  Id. at *5.  But, other claims, such as Ohio common law claims which are subsumed under the Ohio Products Liability Act, were allowed to be pleaded in the alternative.  Id. at *6.             

Regardless of which amendments were or were not allowed, Butler stands for the proposition that the pleading framework under which an MDL is conducted (and any results of Rule 12 motion practice) can be jettisoned after remand.  So, what’s the point?

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Some of your bloggers recently attended the American Conference Institute’s annual Drug and Medical Device Litigation Conference in New York.  One of the conference panels addressed a recent unsettling ruling in a non-drug-device case that held communications training provided by defense counsel for their client’s employees was not only discoverable but admissible at trial.  In re Google Play Store Antitrust Litigation, 664 F. Supp.3d 981, 983 (N.D. Cal. 2023).  Moreover, some of the “practices” that found their way into the opinions seemed to us not only privileged but entirely unobjectionable:

Plaintiffs also point out that, for years, [defendant] has directed its employees to avoid using certain [legal] buzzwords in their communications. . . .  Eight years later, [defendant] still was telling employees . . . “[a]ssume every document you generate … will be seen by regulators.”

United States v. Google LLC, ___ F. Supp.3d ___, 2024 WL 3647498, at *113 (D.D.C. Aug. 5, 2024) (citation omitted).  That’s only good sense, and no different than the other side (at least if they have good lawyers) tells its own individual plaintiffs before they have to testify. 

Continue Reading Privilege and Lawyer-Provided Employee Training

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